Biliary catheter systems including stabilizing members

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser. No. 61/415,649, filed Nov. 19, 2010, the disclosure of which is incorporated herein in its entirety.

TECHNICAL FIELD

The present invention pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present invention pertains to biliary catheter systems and instruments and/or tools that are designed to provide enhanced stabilization during a biliary tree intervention.

BACKGROUND

A wide variety of medical devices have been developed for medical use, for example, endoscopic use. Some of these devices include catheters, catheter systems, endoscopic instruments, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.

BRIEF SUMMARY

The invention provides design, material, manufacturing method, and use alternatives for medical devices such as catheters, catheter systems, endoscopic instruments, biliary catheters and catheter systems, tools including stabilizing tools, and the like. An example biliary catheter system may include an endoscope having a working channel formed therein. An endoscopic instrument may be disposed in the channel. The endoscopic instrument may have a tool channel formed therein, a distal end, and a plurality of stabilizing members extending from the distal end. The plurality of stabilizing members may be configured to surround the ampulla of Vater during a biliary tract intervention.

An example stabilization tool for cannulation of an ampulla of Vater of a patient may include an endoscopic instrument configured to be disposed in a channel of an endoscope. The endoscopic instrument may have a cannulation tool channel formed therein, a distal end, and three or more stabilizing members extending from the distal end for stabilizing the endoscopic instrument relative to the ampulla of Vater during a biliary tract intervention. The stabilizing members may be arranged so as to surround the ampulla of Vater during the intervention. A cannulation tool may be disposed in the cannulation tool channel.

An example method for cannulation of an ampulla of Vater of a patient may include providing an endoscope having a channel formed therein, advancing the endoscope to a position adjacent to the ampulla of Vater and advancing a stabilization and cannulation tool through the channel of the endoscope. The tool may include an endoscopic instrument having a cannulation tool channel formed therein, a distal end, and three or more stabilizing members extending from the distal end. The tool may also include a cannulation tool disposed in the cannulation tool channel. The method may also include arranging the endoscopic instrument so that the stabilizing members surround and stabilize the ampulla of Vater and delivering the cannulation tool to the ampulla of Vater.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

<figref idref="DRAWINGS">FIG. 1</figref> is an overview of the biliary tree;

<figref idref="DRAWINGS">FIG. 2</figref> is a plan view illustrating an example endoscope system disposed adjacent to the ampulla of Vater;

<figref idref="DRAWINGS">FIG. 3</figref> is a partial cross-sectional side view of an example tubular member including a plurality of stabilizing members;

<figref idref="DRAWINGS">FIG. 4</figref> is a partial transverse cross-sectional view of the example tubular member illustrated in <figref idref="DRAWINGS">FIG. 3</figref>;

<figref idref="DRAWINGS">FIG. 4A</figref> is a plan view of a portion of an example stabilizing member;

<figref idref="DRAWINGS">FIG. 4B</figref> is a plan view of a portion of another example stabilizing member;

<figref idref="DRAWINGS">FIG. 5</figref> is a plan view illustrating another example endoscope system disposed adjacent to the ampulla of Vater;

<figref idref="DRAWINGS">FIG. 6</figref> is a partial cross-sectional side view of another example tubular member including a plurality of stabilizing members;

<figref idref="DRAWINGS">FIG. 7</figref> is an end view of the example tubular member illustrated in <figref idref="DRAWINGS">FIG. 6</figref>; and

<figref idref="DRAWINGS">FIG. 8</figref> is a plan view illustrating another example endoscope system disposed adjacent to the ampulla of Vater.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Endoscopic retrograde cholangiopancreatography (ERCP) is used primarily to diagnose and treat conditions of the bile ducts including, for example, gallstones, inflammatory strictures, leaks (e.g., from trauma, surgery, etc.), and cancer. Through the endoscope, the physician can see the inside of the stomach and duodenum, and inject dyes into the ducts in the biliary tree and pancreas so they can be seen on x-rays. These procedures may necessitate gaining and keeping access to the biliary duct, which may be technically challenging, may require extensive training and practice to gain proficiency, and may require one or more expensive tools in order to perform.

During an ERCP procedure, a number of steps are typically performed while the patient is often sedated or anaesthetized. For example, an endoscope may be inserted through the mouth, down the esophagus, into the stomach, through the pylorus into the duodenum, to a position at or near the ampulla of Vater (the opening of the common bile duct and pancreatic duct). Due to the shape of the ampulla and the angle at which the common bile and pancreatic ducts meet the wall of the duodenum, the distal end of the endoscope is generally placed just past the ampulla. Due to the positioning of the endoscope beyond the ampulla, the endoscopes used in these procedures are usually side-viewing endoscopes. The side-viewing feature provides imaging along the lateral aspect of the tip rather than from the end of the endoscope. This allows the clinician to obtain an image of the medial wall of the duodenum, where the ampulla of Vater is located, even though the distal tip of the endoscope is beyond the opening.

Next, a clinician may cannulate the entrance to the pancreatic and bile ducts, which are located beyond the ampulla of Vater, with a catheter or cannula placed through the instrument channel of the endoscope. The catheters are directed cranially at an angle with respect to the distal end of the endoscope, so as to facilitate insertion into the opening. Once in place within the ampulla, a radiocontrast agent can be injected into the bile ducts and/or pancreatic duct. Fluoroscopy can then be used to identify and treat various ailments, including blockages or leakage of bile into the peritoneum (abdominal cavity).

Because the ampulla of Vater is positioned within the duodenum, and because the duodenum may be moving due to peristalsis, positioning and cannulating the ampulla of Vater may be challenging. Disclosed herein are systems, tools, and methods for cannulating the ampulla of Vater during the diagnosis and treatment of biliary, hepatic, gallbladder, and/or pancreatic disease or other ailments. The systems, tools, and methods disclosed are generally directed at improving the ability of a user to cannulate the ampulla of Vater by helping to stabilize a portion of the duodenum near the ampulla during the cannulization procedure.

<figref idref="DRAWINGS">FIG. 1</figref> provides an overview of the biliary system or tree. Illustrated is a portion of the duodenum <b>12</b> where the ampulla of Vater <b>14</b> is located. For the purposes of this disclosure, the ampulla of Vater <b>14</b> is understood to be the same anatomical structure as the papilla of Vater. The ampulla of Vater <b>14</b> generally forms the opening where the pancreatic duct <b>16</b> and the bile duct <b>18</b> can empty into the duodenum <b>12</b>. The hepatic ducts, generally bearing reference number <b>20</b>, are connected to the liver <b>22</b> and empty into the bile duct <b>18</b>. Likewise, the cystic duct <b>24</b>, which is connected to the gall bladder <b>26</b>, also empties into the bile duct <b>18</b>. In general, an endoscopic or biliary procedure may include advancing a medical device to a suitable location along the biliary tree and then performing the appropriate intervention.

<figref idref="DRAWINGS">FIG. 2</figref> illustrates a distal portion of an endoscope system <b>10</b> that has advanced through the mouth of a patient, through the stomach, and into the duodenum <b>12</b> adjacent the ampulla of Vater <b>14</b>. In order to gain access the biliary tree, system <b>10</b> and/or a catheter or cannulation tool will “cannulate” or otherwise pass through the ampulla of Vater <b>14</b>. However, due to peristalsis the duodenum <b>12</b> adjacent the ampulla of Vater <b>14</b> may be moving, which may make it technically difficult to cannulate the ampulla of Vater <b>14</b>. In order to more efficiently cannulate the ampulla of Vater <b>14</b>, system <b>10</b> may include a stabilizing assembly <b>28</b> that functions by “stabilizing” or otherwise helping reduce the peristaltic motion of the duodenum <b>12</b> so that a clinician can cannulate the ampulla of Vater <b>14</b> in a relatively simple and time-efficient manner.

In at least some embodiments, stabilizing assembly <b>28</b> includes a plurality of stabilizing members including a first stabilizing member <b>28</b><i>a</i>, a second stabilizing member <b>28</b><i>b</i>, and a third stabilizing member <b>28</b><i>c</i>. In use, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>can be disposed about the ampulla of Vater <b>14</b>. This may include positioning stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>so they surround or otherwise are disposed along multiple points of the periphery of the ampulla of Vater <b>14</b>. Such positioning may be desirable for a number of reasons. For example, positioning stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>so that they surround the ampulla of Vater <b>14</b> may allow stabilizing assembly <b>28</b> to sufficiently stabilize the duodenum <b>12</b>, which may be moving due to peristalsis, so that a cannulation tool <b>34</b> can cannulate the ampulla of Vater <b>14</b>. In addition, because stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may be disposed along “all sides” of the ampulla of Vater <b>14</b>, the ampulla of Vater <b>14</b> may be more fully stabilized than if system <b>10</b> was just secured to one or two points along the wall of the duodenum <b>12</b>.

<figref idref="DRAWINGS">FIG. 3</figref> is a partial cross-section side view of system <b>10</b> and provides some additional details regarding system <b>10</b>. Here it can be seen that system <b>10</b> may include a tubular member <b>11</b>. In some embodiments, tubular member <b>11</b> is a portion of an endoscope or is the shaft of an endoscope. In other embodiments, tubular member <b>11</b> is an endoscopic instrument or tool that is configured to be disposed in a channel or lumen formed in an endoscope. According to this later embodiment, tubular member <b>11</b> may be configured to be advanced through a channel formed in an endoscope and extend out from a port at or near the distal end (e.g., including a side port formed along a side surface) of the endoscope.

Tubular member <b>11</b> may have a plurality of lumens or channels formed therein. For example, a first lumen <b>30</b><i>a </i>and a second lumen <b>30</b><i>b </i>may be formed in tubular member <b>11</b>. A third lumen <b>30</b><i>c </i>may also be formed in tubular member <b>11</b> as more clearly seen in <figref idref="DRAWINGS">FIG. 4</figref>. Stabilizing assembly <b>28</b> may be disposed within tubular member <b>11</b>. For example, first stabilizing member <b>28</b><i>a </i>may be disposed in first lumen <b>30</b><i>a</i>, second stabilizing member <b>28</b><i>b </i>may be disposed in second lumen <b>30</b><i>b</i>, and third stabilizing member <b>28</b><i>c </i>may be disposed in third lumen <b>30</b><i>c </i>as shown in <figref idref="DRAWINGS">FIG. 4</figref>.

The precise structural arrangement of stabilizing assembly <b>28</b> relative to tubular member <b>11</b> may vary. For example, in the embodiment illustrated in <figref idref="DRAWINGS">FIGS. 2-4</figref>, the various stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>of stabilizing assembly <b>28</b> are separately disposed in lumens <b>30</b><i>a</i>/<b>30</b><i>b</i>/<b>30</b><i>c </i>of tubular member <b>11</b>, respectively. At a proximal portion <b>38</b> of tubular member <b>11</b>, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may be secured to an actuation or advancing mechanism (not shown) that allows stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>to be advanced out from and be retracted back into a distal portion <b>36</b> of tubular member. The actuation mechanism may be an integrated structure that allows all three of stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>to be advanced or retracted together. Alternatively, the proximal ends of stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may be accessible to the clinician so that each can be independently advanced and/or retracted to the extent desired so as to best perform the intended intervention. Numerous other arrangements, configurations, and/or actuation mechanisms are contemplated.

In order to assist with stabilizing the duodenum <b>12</b>, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may comprise vacuum lumens that are configured to extend out from the distal portion <b>36</b> of tubular member <b>11</b> and engage the wall of the duodenum <b>12</b>. Once engaged, a vacuum can be applied to stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>(e.g., to vacuum channels defined by generally tubular stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>and/or through lumens <b>30</b><i>a</i>/<b>30</b><i>b</i>/<b>30</b><i>c</i>), via a vacuum source <b>40</b> coupled to the proximal portion <b>38</b> of tubular member <b>11</b>, so that stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>can adhere to and hold on to the wall of the duodenum <b>12</b>. Because stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>surround or are otherwise disposed at multiple positions along the periphery of the ampulla of Vater <b>14</b>, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>can reduce the peristaltic motion of the duodenum <b>12</b> adjacent the ampulla of Vater <b>14</b> so that a clinician can cannulate the ampulla of Vater <b>14</b> in an efficient manner.

In at least some embodiments, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may be biased to project somewhat radially outward when extending out from distal portion <b>36</b> of tubular member <b>11</b>. This may be desirable, for example, because it may create a “fan-like” or funnel-shaped orientation of stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c</i>. The shape of this configuration may also be described as being triangular. Because of this, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may more easily surround the ampulla of Vater <b>14</b>. In some embodiments, stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>may be biased by simply being arranged in a slightly bent or bowed configuration prior to being disposed in lumens <b>30</b><i>a</i>/<b>30</b><i>b</i>/<b>30</b><i>c </i>such that extending stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>out from distal portion <b>36</b> allows stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>to resume their bent configuration. Alternatively, one or more biasing springs or levers may be disposed adjacent distal portion <b>36</b> that exert a radially outward force on stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>so as to help stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>take the desired configuration. In some embodiments, the angle or bend at which stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>are oriented can be adjusted. This may include the use of pull wires (not shown, which may extend down lumens <b>30</b><i>a</i>/<b>30</b><i>b</i>/<b>30</b><i>c</i>) or any other suitable bending mechanism. Numerous other configurations are contemplated for orienting or adjusting the shape configuration of stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>including, for example, guides formed at distal portion <b>36</b> that may function analogously to the guides described below and shown in <figref idref="DRAWINGS">FIG. 7</figref>.

Cannulation may occur through the use of a cannulation tool <b>32</b> that may extend through a cannulation tool lumen <b>34</b> formed in tubular member <b>11</b>. The form of cannulation tool <b>32</b> may vary widely. In some embodiments, cannulation tool <b>32</b> may be a catheter, a stent (e.g., a biliary or “drainage” stent) delivery system, tomes or cutting devices, balloon devices, ERCP devices, needle devices, knife devices, or the like. For example, in <figref idref="DRAWINGS">FIG. 3</figref>, cannulation tool <b>32</b> is illustrated as a sphincterotome that may be utilized to help cannulate the ampulla of Vater <b>14</b> and/or other portions of the biliary tree. In general, cannulation tool <b>32</b> is brought to the area of interest by placing tool <b>32</b> adjacent to stabilizing assembly <b>28</b>. This may include passing tool <b>32</b> through lumen <b>34</b> or otherwise disposing tool <b>34</b> near stabilizing assembly.

While <figref idref="DRAWINGS">FIGS. 2-4</figref> illustrate stabilizing assembly <b>28</b> as having three stabilizing members <b>28</b><i>a</i>/<b>28</b><i>b</i>/<b>28</b><i>c </i>taking the form of vacuum lumens, this is not intended to be limiting as the precise number and form of stabilizing assembly <b>28</b> may vary. For example, stabilizing assembly <b>28</b> may include any suitable number of stabilizing members including one, two, three, four, five, six, seven, eight, nine, ten, or more. These stabilizing members may all have essentially the same structure or form or they may vary from one another. For example, some stabilizing members may take the form of vacuum lumens whereas others may have another form that may desirably aid in stabilizing the wall of the duodenum <b>12</b>. Some examples of other types of stabilizing members are disclosed herein. Numerous other stabilizing members and/or combinations of stabilizing members are contemplated.

It can be appreciated that the shape or pattern formed by stabilizing assembly <b>28</b> or other stabilizing assemblies disclosed or contemplated herein may vary depending on the number of stabilizing members utilized and, for example, the shape that may best be suited for surrounding the ampulla of Vater <b>14</b>. For example, stabilizing assembly <b>28</b> may have a generally triangular shape when disposed about the ampulla of Vater <b>14</b>. Other shapes, however, are contemplated particularly when a different numbers of stabilizing members are utilized in stabilizing assembly <b>28</b>. For example, four stabilizing members may take the form of a square or rectangular shape. Other shapes are contemplated such as a pentagon, a hexagon, a heptagon, an octagon, a nonagon, a decagon, a generally circular shape, a generally oval shape, a star shape, a pill shape, etc.

In addition, each of the stabilizing members may extend through an individual (e.g., its own) lumen formed in tubular member <b>11</b> as shown in <figref idref="DRAWINGS">FIGS. 2-4</figref> or one or more stabilizing members may share a common lumen. Some embodiments may include some stabilizing members that extend through their own individual lumens and some other stabilizing members that share a common lumen in one stabilizing assembly. Numerous other arrangements or differences in form are also contemplated.

In addition, one or more of the stabilizing members may include other structural features that help to further enhance stabilization. For example, <figref idref="DRAWINGS">FIG. 4A</figref> illustrates a stabilizing member bearing reference number <b>28</b>′, which has a curved or bend contact area <b>29</b>′. Area <b>29</b>′ may correspond to the surface of stabilizing member <b>28</b>′ that contacts the target anatomy, for example along the periphery of the ampulla of Vater <b>14</b>. Area <b>29</b>′ may increase the contact area between stabilizing member <b>28</b>′ and the target anatomy. In addition, other stabilizing member are contemplated such as stabilizing member <b>28</b>″, illustrated in <figref idref="DRAWINGS">FIG. 4B</figref>, which includes a plurality of projections or “toes” <b>29</b>″ along its end. Toes <b>29</b>″ may also increase the contact area between stabilizing member <b>28</b>″ and the target anatomy. The features of stabilizing members <b>28</b>′/<b>28</b>″ may be included in any of the stabilizing members disclosed herein. Additionally, other stabilizing members are also contemplated that may include other structural similar to those of stabilizing members <b>28</b>′/<b>28</b>″ such as, for example, a webbed and/or a fanned structure (not shown), which may be configured to expand so as to increase the contact area between the stabilizing member and the target anatomy, for example along the periphery of the ampulla of Vater <b>14</b>.

<figref idref="DRAWINGS">FIGS. 5-7</figref> illustrate another endoscope system <b>110</b>, which may be similar in form and function to system <b>10</b>. System <b>110</b> may include stabilizing assembly <b>128</b>, which may include three stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>that are configured to extend out from tubular member <b>111</b> and surround or otherwise be disposed at multiple positions along the periphery of the ampulla of Vater <b>14</b> in order to stabilize the ampulla of Vater <b>14</b>. In the illustrated embodiment, for example as shown in <figref idref="DRAWINGS">FIG. 6</figref>, stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>may be disposed in lumen <b>130</b>. Lumen <b>130</b> may be a single, common lumen <b>130</b> through which all of stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>may extend. However, this is not intended to be limiting as other embodiments are contemplated where each individual stabilizing lever <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>extends through its own lumen formed in tubular member <b>111</b>.

Stabilizing members <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>may have a sharpened or otherwise pointed end that may allow stabilizing members <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>to engage and secure with duodenum <b>12</b>. It can be appreciated that these pointed ends have points of a suitable size so as to effectively engage duodenum <b>12</b> while minimizing any potential damage to the wall of the duodenum <b>12</b>. In other embodiments, stabilizing members <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>may be roughened or otherwise altered so that they can frictionally engage duodenum <b>12</b> and, thus, secure stabilizing assembly <b>128</b> to the wall of the duodenum <b>12</b>.

Stabilizing members <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>can be advanced out from distal portion <b>136</b> of tubular member <b>111</b> so as to be brought into contact with the duodenum <b>12</b>. When in contact with the duodenum <b>12</b>, cannulation tool <b>132</b>, which may be similar in form and function to other tools disclosed herein, may extend through lumen <b>134</b> and cannulate the ampulla of Vater <b>14</b>.

Just like in stabilizing assembly <b>28</b>, stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>may be biased to expand radially outward when advanced out of distal portion <b>136</b> of tubular member <b>111</b>. This may be due to the material or shape of stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>(e.g., stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>may have a bent configuration when not disposed in lumen <b>130</b>), due to a spring or a biasing structure, or due to any other suitable structural arrangement.

<figref idref="DRAWINGS">FIG. 7</figref> is an end view of system <b>110</b>. Here it can be seen that tubular member <b>111</b> may include a plurality of guides such as a first guide <b>142</b><i>a</i>, a second guide <b>142</b><i>b</i>, a third guide <b>142</b><i>c </i>that help guide stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>to the desired configuration about the ampulla of Vater <b>14</b>. Guides <b>142</b><i>a</i>/<b>142</b><i>b</i>/<b>142</b><i>c </i>may serve as a structure that help orient stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>in the desired configuration, which in this case may be a generally triangular shape that can essentially surround the ampulla of Vater <b>14</b>. To orient stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c</i>, guides <b>142</b><i>a</i>/<b>142</b><i>b</i>/<b>142</b><i>c </i>may form a structural barrier that may limit the radial expansion of stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>so that stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>can form a substantially “tight” triangular orientation about the ampulla of Vater <b>14</b>. It can be appreciated that guides <b>142</b><i>a</i>/<b>142</b><i>b</i>/<b>142</b><i>c </i>can be arranged so that stabilizing legs <b>128</b><i>a</i>/<b>128</b><i>b</i>/<b>128</b><i>c </i>expand to the degree desired and in some embodiments, guides <b>142</b><i>a</i>/<b>142</b><i>b</i>/<b>142</b><i>c </i>may be adjustable by the clinician (either before or during an intervention) so that the extent of radial expansion can be altered to best suit the needs of a given intervention.

Another endoscope system <b>210</b> is illustrated in <figref idref="DRAWINGS">FIG. 8</figref>. System <b>210</b> may include a stabilizing clip <b>228</b> that can extend from system <b>210</b> so that cannulation tool <b>232</b> can cannulate the ampulla of Vater <b>14</b>. Clip <b>228</b> may generally be configured to engage a portion of the wall of the duodenum <b>12</b> and secure it with the jaws of the clip <b>228</b>. Clip <b>228</b> may be actuated by a control member or wire (not shown) that may extend within system <b>210</b> and be accessible to the clinician.

While system <b>210</b> is illustrated as having only a singular stabilizing structure (e.g., stabilizing clip <b>228</b>), it is contemplated that clip <b>228</b> may be used in combination with and/or form part of any of the other stabilizing assembly disclosed herein. For example, stabilizing assembly <b>28</b> and/or stabilizing assembly <b>128</b> may include clip <b>228</b>. In such embodiments, clip <b>228</b> may share one of the lumens of the respective tubular member <b>11</b>/<b>111</b> or it may be disposed in a separate lumen formed in the respective tubular member <b>11</b>/<b>111</b>.

The materials that can be used for the various components of system <b>10</b> (and/or other systems disclosed herein) may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to system <b>10</b>, tubular member <b>11</b>, and stabilizing assembly <b>28</b>. However, this is not intended to limit the invention as the discussion may be applied to other similar members and/or components of members or systems disclosed herein.

Tubular member <b>11</b>, stabilizing assembly <b>28</b>, and/or other components of system <b>10</b> may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, combinations thereof, and the like, or any other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

As alluded to above, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2-0.44% strain before plastically deforming.

In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by DSC and DMTA analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60° C. to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties and has essentially no yield point.

In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of tubular member <b>11</b> and/or stabilizing assembly <b>28</b> may also be doped with, made of, or otherwise include a radiopaque material including those listed herein or other suitable radiopaque materials. In some embodiments, a degree of MRI compatibility is imparted into system <b>10</b>.

For example, to enhance compatibility with Magnetic Resonance Imaging (MRI) machines, it may be desirable to make tubular member <b>11</b> and/or stabilizing assembly <b>28</b> in a manner that would impart a degree of MRI compatibility. For example, tubular member <b>11</b>, stabilizing assembly <b>28</b>, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (artifacts are gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Tubular member <b>11</b>, stabilizing assembly <b>28</b>, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

Some examples of suitable polymers that may be used to form tubular member <b>11</b>, stabilizing assembly <b>28</b>, and/or other components of system <b>10</b> may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

In some embodiments, the exterior surface of the system <b>10</b> may include a coating, for example a lubricious, a hydrophilic, a protective, or other type of coating. Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves device handling and exchanges. Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers may include silicone and the like, polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility. Some other examples of such coatings and materials and methods used to create such coatings can be found in U.S. Pat. Nos. 6,139,510 and 5,772,609, the entire disclosures of which are incorporated herein by reference. Other coatings may be utilized, as desired, to increase surface friction or otherwise add a tacky or adhesive-like (e.g., sticky) feel.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.